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    Clinical Trial Results:
    A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections.

    Summary
    EudraCT number
    2009-015953-18
    Trial protocol
    LT   CZ   PL   LV   DE   Outside EU/EEA  
    Global end of trial date
    26 Jun 2013

    Results information
    Results version number
    v2(current)
    This version publication date
    09 Jun 2016
    First version publication date
    23 Jul 2015
    Other versions
    v1
    Version creation reason
    • Correction of full data set
    Review of data

    Trial information

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    Trial identification
    Sponsor protocol code
    DORIPED3002
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01110408
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Turnhoutseweg 30, 2340 Beerse, Belgium, Belgium,
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, ClinicalTrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000015-PIP01-07
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    Yes
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    26 Jun 2013
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    26 Jun 2013
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jun 2013
    Was the trial ended prematurely?
    Yes
    General information about the trial
    Main objective of the trial
    The primary objective of this study is to establish the safety and tolerability profile of doripenem compared with that of cefepime in hospitalized children 3 months to less then 18 years of age with cUTI (complicated Urinary Tract Infection).
    Protection of trial subjects
    This study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and that are consistent with Good Clinical Practices and applicable regulatory requirements. An Independent Data Monitoring Committee [IDMC] monitored the safety of participants in this study as well as 2 additional Phase 3 pediatric trials being conducted by the Sponsor simultaneously. Safety evaluations included the measurement of vital signs, monitoring of reported adverse effects (AEs), including serious adverse effects (SAEs), concomitant therapy, serum chemistry, hematology assessments, and urinalysis with microscopy.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    09 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    Yes
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Ukraine: 10
    Country: Number of subjects enrolled
    United States: 3
    Country: Number of subjects enrolled
    Chile: 1
    Country: Number of subjects enrolled
    Colombia: 7
    Country: Number of subjects enrolled
    Czech Republic: 7
    Country: Number of subjects enrolled
    Latvia: 1
    Country: Number of subjects enrolled
    Lithuania: 5
    Country: Number of subjects enrolled
    Mexico: 3
    Country: Number of subjects enrolled
    Panama: 1
    Country: Number of subjects enrolled
    Poland: 2
    Worldwide total number of subjects
    40
    EEA total number of subjects
    15
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    16
    Children (2-11 years)
    19
    Adolescents (12-17 years)
    5
    Adults (18-64 years)
    0
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    A minimum of 120 participants were to be randomly assigned to IV doripenem or IV cefepime in this study in approximate 3:1 ratio. 41 participants were enrolled and 40 participants were treated in this study.

    Pre-assignment
    Screening details
    A total of 41 participants were enrolled and randomized in the study; 30 participants received doripenem and 10 participants received cefepime. One participant in the doripenem treatment group, after being randomized, was excluded from the study due to protocol violation.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator, Carer, Assessor

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Doripenem
    Arm description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
    Arm type
    Experimental

    Investigational medicinal product name
    Doripenem
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 milligram per dose[mg/dose]) will be administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV ( at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin).

    Arm title
    Cefepime
    Arm description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (atleast 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.
    Arm type
    Active comparator

    Investigational medicinal product name
    Cefepime
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Powder and solvent for solution for injection/infusion
    Routes of administration
    Intravenous use
    Dosage and administration details
    Cefepime 50 milligram per kilogram (mg/kg) per dose (up to 2 gram per dose g/dose) will be administered every 8 hours as 30 minutes intravenous ( at least 3 day of intravenous IV cefepime only or IV cefepime followed by oral amoxicillin/ clavulanate potassium or ciprofloxacin).

    Number of subjects in period 1
    Doripenem Cefepime
    Started
    30
    10
    Completed
    30
    10

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (atleast 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group values
    Doripenem Cefepime Total
    Number of subjects
    30 10 40
    Title for AgeCategorical
    Units: subjects
        Infants and toddlers (28 days-23 months)
    12 4 16
        Children (2-11 years)
    14 5 19
        Adolescents (12-17 years)
    4 1 5
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    4.6 ± 5.22 4.3 ± 4.16 -
    Title for Gender
    Units: subjects
        Female
    26 5 31
        Male
    4 5 9

    End points

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    End points reporting groups
    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (atleast 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Subject analysis set title
    Clinical Intent-to-Treat (CITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    All randomized participants who met the minimal disease definition of complicated urinary tract infection regardless if a baseline pathogen was isolated from the pretreatment urine culture.

    Subject analysis set title
    Microbiological intent-to-treat (MITT)
    Subject analysis set type
    Intention-to-treat
    Subject analysis set description
    Participants of all CITT with at least 1 baseline bacterial pathogen isolated from the pretreatment urine culture, susceptible to both doripenem and cefepime. 6 and 2 participants from doripenem and cefepime, respectively had no susceptible urine pathogens at baseline and were excluded from this set.

    Primary: The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit

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    End point title
    The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
    End point description
    The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit.
    End point type
    Primary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    30 [1]
    10 [2]
    Units: Participants
        number (not applicable)
    20
    5
    Notes
    [1] - Clinical Intent-To-Treat
    [2] - Clinical Intent-To-Treat
    Statistical analysis title
    Statistical analysis 1
    Comparison groups
    Doripenem v Cefepime
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [3]
    Method
    Parameter type
    Difference clinical cure rates (%)
    Point estimate
    16.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -25.3
         upper limit
    58.6
    Notes
    [3] - Descriptive study.

    Secondary: The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit

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    End point title
    The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
    End point description
    The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun.
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    30 [4]
    10 [5]
    Units: Participants
        number (not applicable)
    28
    10
    Notes
    [4] - Clinical Intent-To-Treat
    [5] - Clinical Intent-To-Treat
    Statistical analysis title
    Statistical analysis 2
    Comparison groups
    Doripenem v Cefepime
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [6]
    Method
    Parameter type
    Diff. clinical improvement rates (%)
    Point estimate
    -6.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -22.3
         upper limit
    8.9
    Notes
    [6] - Descriptive study.

    Secondary: The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit

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    End point title
    The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
    End point description
    The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure.
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    30 [7]
    10 [8]
    Units: Participants
        number (not applicable)
    18
    5
    Notes
    [7] - Clinical Intent-To-Treat
    [8] - Clinical Intent-To-Treat
    Statistical analysis title
    Statistical analysis 3
    Comparison groups
    Doripenem v Cefepime
    Number of subjects included in analysis
    40
    Analysis specification
    Pre-specified
    Analysis type
    other [9]
    Method
    Parameter type
    Difference clinical cure rates (%)
    Point estimate
    10
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -32.3
         upper limit
    52.3
    Notes
    [9] - Descriptive study

    Secondary: The Number of Participants With Favorable Per-participant Microbiological Response

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    End point title
    The Number of Participants With Favorable Per-participant Microbiological Response
    End point description
    Favourable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favourable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    24 [10]
    8 [11]
    Units: participants
    number (not applicable)
        EIV visit
    24
    8
        TOC visit
    19
    4
        LFU visit
    16
    4
    Notes
    [10] - Microbiological intent-to-treat
    [11] - Microbiological intent-to-treat
    Statistical analysis title
    Favorable Microbiological Response (MR) at TOC
    Comparison groups
    Doripenem v Cefepime
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    other [12]
    Method
    Parameter type
    Difference MR Rate (%)
    Point estimate
    29.92
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -17.4
         upper limit
    75.8
    Notes
    [12] - Descriptive study
    Statistical analysis title
    Favorable Microbiological Response (MR) at LFU
    Comparison groups
    Doripenem v Cefepime
    Number of subjects included in analysis
    32
    Analysis specification
    Pre-specified
    Analysis type
    other [13]
    Method
    Parameter type
    Difference MR Rate (%)
    Point estimate
    16.7
    Confidence interval
         level
    95%
         sides
    2-sided
         lower limit
    -31.1
         upper limit
    64.4
    Notes
    [13] - Descriptive study

    Secondary: Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit

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    End point title
    Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
    End point description
    The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
    End point type
    Secondary
    End point timeframe
    EIV (within 24 hours after completion of the last dose of IV study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    24 [14]
    8 [15]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n=3, 0)
    3
    0
        Escherichia coli (n=22, 7)
    22
    7
        Klebsiella oxytoca (n=1, 0)
    1
    0
        Klebsiella pneumoniae (n=1, 1)
    1
    1
    Notes
    [14] - Microbiological intent-to-treat
    [15] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Secondary: Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit

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    End point title
    Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
    End point description
    The favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
    End point type
    Secondary
    End point timeframe
    TOC (7 to 14 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    24 [16]
    8 [17]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n=3, 0)
    3
    0
        Escherichia coli (n=22, 7)
    17
    4
        Klebsiella oxytoca (n=1, 0)
    1
    0
        Klebsiella pneumoniae (n=1, 1)
    1
    0
    Notes
    [16] - Microbiological intent-to-treat
    [17] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Secondary: Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit

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    End point title
    Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
    End point description
    The sustained favourable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively).
    End point type
    Secondary
    End point timeframe
    LFU (28 to 42 days after the last dose of study medication therapy)
    End point values
    Doripenem Cefepime
    Number of subjects analysed
    24 [18]
    8 [19]
    Units: Participants
    number (not applicable)
        Staphylococcus aureus (n= 3, 0)
    2
    0
        Escherichia coli (n= 22, 7)
    14
    4
        Klebsiella oxytoca (n= 1, 0)
    1
    0
        Klebsiella pneumoniae (n= 1, 1)
    1
    0
    Notes
    [18] - Microbiological intent-to-treat
    [19] - Microbiological intent-to-treat
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Timeframe for AE
    Assessment type
    Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.0
    Reporting groups
    Reporting group title
    Cefepime
    Reporting group description
    Cefepime 50 milligram per kilogram [mg/kg] per dose (up to 2 gram per dose [g/dose]) was administered every 8 hours as 30-minutes intravenous [IV] (atleast 3 days of IV cefepime only or IV cefepime followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Reporting group title
    Doripenem
    Reporting group description
    Doripenem 20 milligram per kilogram [mg/kg] per dose (up to 500 mg/dose) was administered every 8 hours as 60-minutes intravenous [IV] (at least 3 days of IV doripenem only or IV doripenem followed by oral amoxicillin/clavulanate potassium or ciprofloxacin). Total duration of treatment 10 to 14 days.

    Serious adverse events
    Cefepime Doripenem
    Total subjects affected by serious adverse events
         subjects affected / exposed
    3 / 10 (30.00%)
    1 / 30 (3.33%)
         number of deaths (all causes)
    0
    0
         number of deaths resulting from adverse events
    Renal and urinary disorders
    Pyuria
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences causally related to treatment / all
    0 / 0
    0 / 1
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Infections and infestations
    Pseudomembranous Colitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    1 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Pyelonephritis Acute
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 1
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Urinary Tract Infection
         subjects affected / exposed
    2 / 10 (20.00%)
    0 / 30 (0.00%)
         occurrences causally related to treatment / all
    0 / 2
    0 / 0
         deaths causally related to treatment / all
    0 / 0
    0 / 0
    Frequency threshold for reporting non-serious adverse events: 3%
    Non-serious adverse events
    Cefepime Doripenem
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 10 (60.00%)
    16 / 30 (53.33%)
    Vascular disorders
    Phlebitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    General disorders and administration site conditions
    Infusion Site Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Hyperthermia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Irritability
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Pyrexia
         subjects affected / exposed
    1 / 10 (10.00%)
    3 / 30 (10.00%)
         occurrences all number
    1
    8
    Vessel Puncture Site Pain
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    2
    0
    Injury, poisoning and procedural complications
    Overdose
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Investigations
    Alanine Aminotransferase Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Aspartate Aminotransferase Increased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Basophil Count Increased
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Platelet Count Decreased
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Urine Leukocyte Esterase
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Congenital, familial and genetic disorders
    Congenital Thrombocyte Disorder
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Respiratory, thoracic and mediastinal disorders
    Productive Cough
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Rhinorrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Blood and lymphatic system disorders
    Anaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eosinophilia
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Hypochromic Anaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Leukopenia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Neutropenia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Neutrophilia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Myoclonus
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Eye disorders
    Eye Pain
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Gastrointestinal disorders
    Abdominal Pain Upper
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Diarrhoea
         subjects affected / exposed
    0 / 10 (0.00%)
    2 / 30 (6.67%)
         occurrences all number
    0
    2
    Oral Disorder
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nausea
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Vomiting
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    4
    Hepatobiliary disorders
    Jaundice
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Hyperbilirubinaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Renal and urinary disorders
    Crystalluria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Haematuria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Leukocyturia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Proteinuria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Skin and subcutaneous tissue disorders
    Hyperhidrosis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Papule
         subjects affected / exposed
    1 / 10 (10.00%)
    1 / 30 (3.33%)
         occurrences all number
    1
    1
    Macule
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    2
    Rash
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Skin Haemorrhage
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Musculoskeletal and connective tissue disorders
    Myalgia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Metabolism and nutrition disorders
    Hypoalbuminaemia
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Hypoproteinaemia
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Infections and infestations
    Anal Candidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Candidiasis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Bacteriuria
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Cystitis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Fungal Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Nasopharyngitis
         subjects affected / exposed
    0 / 10 (0.00%)
    3 / 30 (10.00%)
         occurrences all number
    0
    4
    Oral Candidiasis
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Urinary Tract Infection
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1
    Pharyngitis
         subjects affected / exposed
    1 / 10 (10.00%)
    0 / 30 (0.00%)
         occurrences all number
    1
    0
    Varicella
         subjects affected / exposed
    0 / 10 (0.00%)
    1 / 30 (3.33%)
         occurrences all number
    0
    1

    More information

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    Substantial protocol amendments (globally)

    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    31 Mar 2011
    The overall reason for the amendment is to incorporate comments from regulatory authorities and investigators from around the world and update the dosing of amoxicillin/clavulanate potassium to every 12 hours [q12h] (7:1 amoxicillin/clavulanate ratio). Inclusion criteria changes included: the requirement of the presence of urine nitrite and leukocyte esterase by urinalysis at baseline. Clarification of the acceptable methods of urine collection as well as to include further investigation to the possible causes contributing to treatment failure. The amendment also update the precautions for medications administered. As well as includes to specify allowable collection methods for urinalysis and microscopy safety assessments. The amendment also includes the requirement that urinalysis with microscopy and creatinine clearance be calculated at baseline as well as to specify time points for the collection of safety laboratory test. It also includes to align the protocol with the EU pediatric investigational plan (PIP) and to remove details of the IDMC that will be specified in the IDMC charter. The amended protocol includes to revise the pharmacokinetic sample collection and handling methods.

    Interruptions (globally)

    Were there any global interruptions to the trial? Yes
    Date
    Interruption
    Restart date
    01 Jun 2013
    This study was terminated early due to business reasons and not related to safety concerns or issues. NOTE: Interruption date indicates the date on which IDMC was notified of premature termination of trial.
    -

    Limitations and caveats

    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    The major limitation of the study was limited enrollment which precludes a meaningful conclusion about the efficacy and safety of doripenem compared with cefepime.
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